Technical Development Principal Scientist R&D Partners
Overview
R&D Partners seeks a Technical Development Principal Scientist in San Diego to lead analytical method development for cell therapy product release. You will design and execute studies using DoE to develop or adapt analytical methods. This role involves leading experiments, analyzing data, and collaborating with junior staff to ensure high-quality results. It requires expertise in flow cytometry and immunology with proven leadership in method optimization and CMC tech-transfer.
What You'll Do11
- 1Design and execute studies via design of experiment to develop analytical methods for cell therapy product release
- 2Perform risk and gap assessments for analytical methods to enhance compliance and robustness
- 3Execute routine laboratory experiments with junior staff to generate high quality data
- 4Analyze data and recommend next steps to internal and cross departmental audiences
- 5Lead method optimization and remediation initiatives
- 6Transfer analytical methods to QC labs with expertise in flow cytometry and immunology
- 7Collaborate with cross-functional teams to implement CMC technology transfer strategies
- 8Develop and validate analytical control strategies and method qualification processes
- 9Interpret and apply ICH guidances cGMP USP regulatory requirements for analytical development
- 10Maintain proficiency in experimental design and control charts using DoE techniques
- 11Drive continuous improvement in laboratory operations and assay best practices
Requirements6
- 1Masters degree with 6-9+ years experience in analytical development QC technology transfer or method lifecycle management
- 2Ph.D. degree in relevant scientific discipline with 2+ years industry experience
- 3Expertise in flow cytometry and immunology analytical method development
- 4Proven leadership in method optimization and remediation
- 5Experience with CMC tech-transfer and analytical control strategies
- 6Ability to interpret regulatory requirements and apply best practices for method validation
Salary Insight
$116 - $144k per year
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